Formulation Development Strategies for Expediting Small Molecule Oral Dosage Formulations to Phase I Studies

The ability to work smarter has become a critical survival skill in order to move drug candidates forward faster and to maximize the chance for compound success. Pharmaceutical companies of all sizes are under pressure to reach critical milestones faster in spite of challenging molecular properties associated with their candidate, and with limited active pharmaceutical ingredient (API).

There are a host of formulation development options to consider that enable speed to first-in-human studies while conserving API and other resources. Though not all are relevant for commercial scale, API in bottle, powder in bottle, API into capsule, and traditional formulations are all approaches worthy of consideration as possible formulation options for clinical supplies for a Phase I clinical trial.

This webinar will specifically address:

• Strategies for expediting small molecule oral dosage formulations to Phase I studies
• Strategies to overcome challenges associated with poorly soluble compounds
• Technical considerations for liquid in capsule formulations
• Controlled release formulations

Partnering with a specialist for early drug development can significantly reduce product risk and accelerate development timelines. Since 1997, Xcelience has been renowned for reliably expediting drug development and reducing compound risk. Our scientists have considerable experience overcoming challenging physical and chemical properties in a manner that results in improved solubility and compound bioavailability. Our outstanding quality record, development expertise, disciplined project management and willingness to customize enables us to deliver real advantage to pharmaceutical innovators focused on small molecule development.

Speaker

Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC

Paul Skultety has a unique background in Pharmaceutical development combining extensive experience with contract development and pharmaceutical companies. At Xcelience, his role is to provide leadership to Pharmaceutical Development Services. This includes analytical chemistry and formulation development.

Prior to Xcelience, he has held such positions as Vice President of Pharmaceutics at Quintiles, Director of Solids Formulation Development for Hoechst Marion Roussel and various management positions within Marion Merrell Dow and Marion Labs which were predecessors to HMR.

Dr Skultety has a successful track record of developing new chemical entities from pre-IND to commercialization. He has 9 US formulation and composition patents. He has written a number of publications and made numerous scientific presentations. He has been a member of AAPS since its inception.

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